New drug for FNHL

ShadyGuy

U.S. Food and Drug Administration Approves Duvelisib (COPIKTRA) for Relapsed/Refractory Chronic Follicular Lymphoma

 

New York, NY – The U.S. Food and Drug Administration (FDA) announced it has approved the use of duvelisib (COPIKTRA) for the treatment of adult patients with relapsed or refractory chronic FNHL.

Duvelisib (COPIKTRA) received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Duvelisib (COPIKTRA) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

ShadyGuy

Scary stuff

I read up on this drug. Seems 8% of the people who take it die within 30 days. 5% total response. However the patients are well advanced and have very poor health after at least two redimens already completed. Still its anothe weapon. Would probably show much better results when used as an initial montherapy for first treatments. What I like about it is its a pill - no infusions.

Max Former Hodgkins Stage 3

ShadyGuy said:

Scary stuff

I read up on this drug. Seems 8% of the people who take it die within 30 days. 5% total response. However the patients are well advanced and have very poor health after at least two redimens already completed. Still its anothe weapon. Would probably show much better results when used as an initial montherapy for first treatments. What I like about it is its a pill - no infusions.

Stats

Shady,

To have been approved at all, the drug must have some merit.  These disparate numbers require a lot of perspective. 5% achiving "total response" (probably meaning CR) is remarkable since, as you noted, they had to be profoundly ill to qualify (failed two previous, FDA-approved programs).  Between these endpost responses of 'cure' on the one hand, and rapid death on the other, the vast number of responses had to be some middling response that showed some degree of patient improvement. Very likely, the "8% who died within 30 days" would have similiarly died within 30 days or less without it. 

If you do a little research beind drugs that are advertised on TV as "breakthroughs"  (it seems they are mostly for lung cancer), most have shown in clinical trials that they increase life expectancy by a few months to, in some cases, several months.  The clinical history of two drugs against prostate cancer is similiar: Jevtana and Zytiga.  Both were initially approved in the last 7 years or less against "taxane-resistant, metastatic PCa," or PCa that no longer was controlled by a taxane (Taxotere or other chemo drug).  They had to be taken subsequently (not concurrently) and each extended life about 3 to 6 months each.  But today, they are perscribed at the beginning of metastatic prostate treatment, with dramatic results. I know this because I nursed a dear friend who lived alone through his last year of a 13 year fight against prostate cancer.  I was his medical representative during his oncology visits, and took him to most of his treatments. He received Jevtana and Zytiga at the very end, until his death.

So, it is all in how "breakthrough" is defined.

The way these things evolve is usually that a promising drug is tested and approved for one thing.  In ten years, the drug may be a mainstay treatment for other lymphomas, or leukemia, or maybe even some other non-blood cancer (it apparantly is now approved also for CLL).  You are correct that it may well be approved for early, or even first-line treatments some day in the future.   It is all one day at a time.  Wishing you that every new day be a good one,

max

Evarista

More optimistic

Hi Shady.  There a number of studies on this drug, as I'm sure you know.  The ones I've seen are more optimistic.  Remember that people have to have failed several other drug regimens before getting to this one, so the risk-benefit analysis will be skewed as a result.  But anything new in the armamentarium (sp?) is a good thing, IMO.  Be well.

ShadyGuy

Just Thinking .....

This drug interferes with the cloning process which is good, but does it actually kill existing clones or is another drug administered to do that? I know some of the studies used Rituxan along with it. I will be getting R and talking to my onc October 15. I know he is going to want a PET so I plan to go to a major cancer center for that and will talk to them too. Looks like I will eventually need something if my suspicions about my current symptoms prove correct. Only time will tell. Meantime I’m going trout fishing.

Max Former Hodgkins Stage 3

ShadyGuy said:

Just Thinking .....

This drug interferes with the cloning process which is good, but does it actually kill existing clones or is another drug administered to do that? I know some of the studies used Rituxan along with it. I will be getting R and talking to my onc October 15. I know he is going to want a PET so I plan to go to a major cancer center for that and will talk to them too. Looks like I will eventually need something if my suspicions about my current symptoms prove correct. Only time will tell. Meantime I’m going trout fishing.

Trout

My brother did not make it to the site near where Deliverance was filmed this year to trout fish, about 10 miles NW of Wahallah, SC.  They primitive camp at a federal campsite, tents-only allowed.

I hope you catch the limit daily,

max

ShadyGuy

Max Former Hodgkins Stage 3 said:

Trout

My brother did not make it to the site near where Deliverance was filmed this year to trout fish, about 10 miles NW of Wahallah, SC.  They primitive camp at a federal campsite, tents-only allowed.

I hope you catch the limit daily,

max

Never saw Deliverance

but have heard of it. Don’t care much for movies or TV. But I do love trout, especially the brookies.